Identity
- Trade Name
- Revita® Guidewire FDA UDI
- Generic Name
- Gastro-urological guidewire, single-use FDA UDI
- Model / Reference
- FRABF-002V FDA UDI
Identifiers
- Catalog Number
- 50111 FDA UDI
- Primary DI / UDI-DI
- 00816349014840 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Gastro-urological guidewire, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Guidewire Length — 450 Centimeter FDA UDIGuidewire Diameter — 0.35 Inch FDA UDI
Category: Gastro-urological guidewire, single-use
Revita® Guidewire by Lake Region Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Gastro-urological guidewire, single-use.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Lake Region Medical
Sources (1)
- FDA UDI 7bcce559-2980-415d-8af3-1474c925278a 35 fields · synced Jun 9, 2026